Study of Ketorolac Versus Opioid for Pain After Endoscopy (SKOPE): A Double-blinded Randomized Control Trial Comparing Outpatient Analgesic Efficacy of NSAIDs and Opioids in Patients Undergoing Ureteroscopy for Kidney Stones
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 81
- 试验地点
- 1
- 主要终点
- Visual Analog Pain Score
研究概览
简要总结
A double blind randomized controlled trial designed to compare pain control and safety with ketorolac and oxycodone in the post-operative setting for patients undergoing ureteroscopy for treatment of urinary stones. Patients are followed for five days after their surgery as they record their pain scores, medication utilization, and stent related symptoms.
详细描述
Pain is the leading cause for unplanned emergency department visits and readmissions after ureteroscopy (URS), making post-operative analgesic stewardship a priority given the current opioid epidemic. The investigators conducted a double-blinded, randomized controlled trial (RCT), with non-inferiority design, comparing nonsteroidal anti-inflammatory drugs (NSAIDs) to opiates for postoperative pain control in patients undergoing URS for urolithiasis.
Patients were randomized and blinded to either oxycodone (5mg) or ketorolac (10mg), taken as needed, with 3 non-blinded oxycodone rescue pills for breakthrough pain. Primary study outcome was visual analog scale pain score on post-operative days 1-5. Secondary outcomes included medication utilization, side effects, and Ureteral Stent Symptoms Questionnaire (USSQ) scores.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with kidney or ureteral stones confirmed on imaging (CT of the abdomen pelvis) and who elect for definitive treatment via unilateral ureteroscopy at one of two hospital sites within a tertiary care institution
- •Patients who post-operatively receive a unilateral ureteral stent
- •Capable of giving informed consent
- •Capable and willing to fulfill requirements of the study
排除标准
- •Active or history of peptic ulcer disease, gastrointestinal bleeding or perforation
- •History of coronary artery bypass graft surgery
- •History of a bleeding disorder
- •GFR less than 60 mL/min/1.73m2 (MDRD equation)
- •Chronic use of opioid or other pain medication including NSAIDs (greater than 12 weeks)
- •Known allergy to either ketorolac or oxycodone
- •Known or suspected pregnancy
- •Solitary kidney
- •Patients taking anticoagulant medication or antiplatelet medication (e.g. warfarin, clopidogrel, pradaxa, rivaroxaban, apixaban etc).
- •Inability to give informed consent or unable to meet requirements of the study for any reason
研究组 & 干预措施
Oxycodone group
Patients randomized to 20 pills of 5 mg oxycodone by mouth every 6 hours as needed for pain after ureteroscopy.
干预措施: Oxycodone (Drug)
Ketorolac group
Patients randomized to 20 pills of 10 mg ketorolac by mouth every 6 hours as needed for pain after ureteroscopy.
干预措施: Ketorolac (Drug)
结局指标
主要结局
Visual Analog Pain Score
时间窗: 5 days
Patient Reported Visual Analogue Score scored from 0-10 with lower scores equaling less pain.
次要结局
- Number of Study Pills Used(Post-operative days 1 to 5)
- Use of Rescue Medication (Opioid)(post operative day 1-5)